GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of… — Class II medical device recall Z-0096-2019
Ongoing recall by GE Healthcare Finland Oy, reported 2018-10-17, distributed nationwide. When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occ
| Recall number | Z-0096-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Finland Oy, Helsinki, Finland |
| Recall initiated | 2018-09-04 |
| Classified | 2018-10-10 |
| Reported by FDA | 2018-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 47,937 units |
| UPC / GTIN / UDI-DI | 01008406821051 |
| Serial numbers | 0100, 010084068, 01008406821051, 0100840682105118111, 010084068210511811160624, 01008406821051181117072521SPM, 010084068210776111160920, 056SA, 134SA, 17300075SA, 17SA, 1821SPM18040045SA11180124, 21051181116082221SKA16340019SA, 21077611117021721SKA17070272SA, 21SKA16253662GA, 21SKA16380073SA, 34SA, 7010321SKA17010060SA, 7200026SA, SKA1, SKA14426270GA, SKA15311765GA, SKA15321855GA, SKA15422727SA, SKA15443161SA and 475 more |
Product
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
Reason for recall
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0096-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.